(29 days)
The M-Vu™ Viewer Station is intended to be used to display low resolution, non-diagnostic, medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.
The M-Vu™ Viewer Station is a computer-based system that displays digitized. low-resolution, radiographic information. The system is typically used to support a radiologist's review of screening and/or diagnostic mammograms. The system has two main functional components: a commercially available computer with an integrated LCD display and an attached bar code reader. The computer is connected to the M-Vu™ CAD Station via an Ethernet network to download selected radiographic images and Computer-Aided Detection (CAD) results or other annotations. The Viewer Station serves no other purpose than providing convenient viewer support.
The provided 510(k) summary for the M-Vu™ Viewer Station explicitly states:
"8. Discussion of Clinical Tests Performed: Not applicable"
This means that a clinical study was not performed to prove the device meets specific acceptance criteria based on human performance or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on non-clinical tests (software validation and verification testing) and similar intended use and characteristics.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical studies cannot be extracted from this document because such studies were not conducted for this submission.
The document indicates that the device's safety and effectiveness were supported by:
- Non-Clinical Tests: Software validation and verification testing.
- Comparison to Predicate Device: The M-Vu™ Viewer Station was found substantially equivalent to the Second Look® Viewer (K#042697) based on intended use and technological characteristics, with differences (e.g., mouse vs. touch screen, printing options) not raising new questions of safety or effectiveness.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).